MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 412.213S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 412.213s, lot: 7l83987, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 05 feb 2021, expiration date: 01 feb 2031.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Non-sterile product code#: 412.213, non-sterile lot #: 86p5777, manufacturing site: (b)(4), release to warehouse date: 29 jan 2021.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent orif surgery for a femoral neck fracture with fns implants.After surgery on (b)(6) 2022, the patient complained of pain, and subtrochanteric fracture of femur at the area where the locking screw of fns was inserted was confirmed.On (b)(6) 2022, a revision surgery was performed.In the revision surgery, fns implants were removed and replaced with femoral recon nail implants to fix the fracture site.The revision surgery was completed successfully with no surgical delay.No further information is available.This report is for a 5.0mm ti locking scr slf-tpng w/t25 stardrive 38mm-sterile.This is report 4 of 4 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO; via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15364625
• MDR Text Key: 299331761
• Report Number: 8030965-2022-06455
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982275400
• UDI-Public: (01)10886982275400
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 412.213S
• Device Catalogue Number: 412.213S
• Device Lot Number: 7L83987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ANTIROTSCR F/FEM NECK SYST; BOLT F/FEM NECK SYST F/CONSTRUCT LENGTH; PL 1-HO F/FEM NECK SYST TAN
• Patient Outcome(s): Required Intervention